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HCFA MEDICARE DRUG BENEFIT REGULATIONS UPDATE

Executive Summary

HCFA MEDICARE DRUG BENEFIT REGULATIONS UPDATE: the Health Care Financing Administration is targeting August for the publication of the eight proposed regulations implementing Medicare coverage of outpatient prescription drugs under the 1988 Catastrophic Coverage Act. The agency previously had expected the regs would be out in June and July. The proposals will be issued for a 60-day comment period and the agency expects the final rules to be published in early December. Medicare coverage of home intravenous therapy coverage begins Jan. 1, 1990. Many of the regs have left HCFA and are awaiting the approval of Health and Human Services Department Secretary Sullivan. However, some of the regs reportedly have been at the secretary's office for some time. The regs also must be approved by the Office of Management and Budget. Among the regs in the HHS secretary's office are the proposed list of covered drugs for home intravenous therapy. In a draft list circulated in the spring, HCFA had proposed that Medicare will cover about 110 intravenous drugs for home use, including 14 chemotherapeutic agents. However, HCFA reportedly reconsidered its position on covering cancer drugs in response to complaints from nursing groups about the potential liabilities involved in administering chemotherapeutic agents without a physician present. As a result, the upcoming proposal reportedly will exclude cancer drugs from coverage. Other pending regs include proposals regarding coverage of home care services related to I.V. drug administration, home I.V. drug provider conditions of participation and the home I.V. drug fee schedule. Among the broader proposals are regs outlining Medicare coverage of prescription drugs and relating to prescription drug benefit copayments and deductibles. HCFA is also developing regs on drug payment methodology and on conditions of pharmacy participation in the program. The latter is described as running slightly behind the other regs.
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